Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-25 @ 12:19 PM
NCT ID:
NCT01255761
Pre Assignment Details:
The Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
FAS-NRI: For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).
Recruitment Details:
Enrollment began in November 2010. Overall study completion occurred in December 2012.
The Participant Flow consists of the Randomized Set (RS). The RS consists of all subjects randomized into the study.
The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication.
Study:
NCT01255761
Study Brief:
Results Section:
NCT01255761